N/A
N=35
Pilot Testing a Home-Based Rehabilitation Intervention Designed to Improve Outcomes of Frail Veterans Following Cardiothoracic Surgery
Coronary Artery Bypass Graft · Non-cardiac Thoracic Surgery · Frailty
Bottom Line
View on ClinicalTrials.gov: NCT03299101 ↗Enrolled (actual)
35
Serious AEs
20.0%
Results posted
Dec 2020
Primary outcome: Primary: Recruitment Rate — 35 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prehabilitation (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment Rate |
35 | — |
| PRIMARY Retention Rate |
25 | — |
| PRIMARY Adherence Rate |
78.85; 86.30; 64.09 | — |
| SECONDARY Change in Grip Strength Over the Course of Treatment and Recovery. |
31.52; 32.19; 31.13 | 0.872 |
| SECONDARY Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MIP |
71.42; 77.96; 79.82 | 0.256 |
| SECONDARY Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MIP |
60.69; 69.38; 71.43 | 0.003 sig |
| SECONDARY Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MEP |
108.09; 120.81; 123.64 | 0.009 sig |
| SECONDARY Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MEP |
98.48; 111.22; 112.01 | 0.010 sig |
| SECONDARY Change in Pulmonary Function Over the Course of Treatment and Recovery: Max SMIP |
416.55; 434.48; 466.77 | 0.814 |
| SECONDARY Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean SMIP |
364.36; 393.86; 435.94 | 0.419 |
| SECONDARY Serum Prealbumin Over the Course of Treatment and Recovery |
26.27; 26.50; 25.13 | 0.196 |
| SECONDARY Change in Gait Speed Over the Course of Treatment and Recovery |
1.16; 1.33; 1.36 | 0.001 sig |
| SECONDARY Change in Short Physical Performance Battery (SPPB) Over the Course of Treatment and Recovery |
10.44; 10.83; 10.64 | 0.854 |
| SECONDARY Change in Risk Analysis Index of Frailty (RAI) Over the Course of Treatment and Recovery |
17.85; 20.40; 23.30 | 0.067 |
| SECONDARY Change in 7-point Subjective Global Assessment (SGA) of Nutrition Over the Course of Treatment and Recovery |
6.04; 6.00; 5.95 | 0.860 |
| SECONDARY Change in 6 Minute Walk Test Over the Course of Treatment and Recovery |
366.49; 400.33; 386.96 | 0.362 |
| SECONDARY Change in Health Related Quality of Life Over the Course of Treatment and Recovery |
0.72; 0.75; 0.77 | 0.068 |
Summary
Frail Veterans are at increased risk for poor surgical outcomes, and as the Veteran population grows older and more frail, there is a critical need to identify effective strategies for reducing surgical risks for these patients. Prior research shows that inter-disciplinary rehabilitation strategies deployed after surgery enhance recovery and improve outcomes by building strength and improving nutrition. The investigators believe that similar improvements may be obtained by using similar interventions before surgery to "prehabilitate" patients' capacity to tolerate the stress of surgery. The proposed research will examine the feasibility of a new, home-based prehabilitation intervention aimed at improving surgical outcomes after cardiothoracic surgery through preoperative exercise training and nutritional supplementation. Findings from the study will inform the design of a larger randomized controlled trial of the prehabilitation intervention. If proven effective, prehabilitation could benefit as many as 42,000 frail Veterans who are scheduled for major elective surgery each year.
Eligibility Criteria
Inclusion Criteria
- Veteran patient scheduled for Coronary artery bypass graft (CABG), valve surgery, or other non-cardiac thoracic surgery;
- Demonstrate at least mild frailty (e.g., Risk Analysis Index [RAI]>=16).
- Physician/provider request for patients with RAI 40 or >10 mm Hg, respectively)
- Dynamic LV (Left Ventricle) outflow obstruction
- Physical, cognitive, social or logistical limitations preventing participation in the prehabilitation regimen, including:
- Patients who require surrogate consent for the planned surgery
- Patients with court orders of incompetence or clinical determinations of incapacity documented in the medical record
- Clinical exam by study physician consistent with incapacity
- Patients who at any time during prehabilitation or longitudinal follow up demonstrate insufficient cognitive capacity to safely and effectively carry out the prescribed activities.
- Unable to speak English.
- Surgery is cancelled by IMPACT clinic or surgeon due to unacceptable risk.
Data sourced from ClinicalTrials.gov (NCT03299101). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.